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Page 394 Sadagopan et al. Art Int Surg 2024;4:387-400 https://dx.doi.org/10.20517/ais.2024.34

Table 3. FDA-approved robotic spine surgery systems
Device or system Manufacturer Function Automation stage
da Vinci Surgical System Intuitive Surgical Inc. Minimally invasive laparoscopic surgery Stage 0-1
Mazor X Stealth Edition Medtronic Pedicle screw insertion, TLIF, and MIDLF Stage 1
ROSA Spine Medtech Pedicle screw insertion and TLIF Stage 2
ExcelsiusGPS Globus Medical Fluoroscopy-guided pedicle screw insertion Stage 2
Renaissance Mazor Robotics Pedicle screw insertion Stage 1
SpineAssist Mazor Robotics Pedicle screw insertion Stage 1
FDA: Food and Drug Administration; TLIF: transforaminal lumbar interbody fusion; MIDLF: midline lumbar interbody fusion.

additional custom attachments to support transforaminal lumbar interbody fusion (TLIF), midline lumbar
[32]
interbody fusion (MIDLF), and deformity-correction procedures . The Mazor X system has particularly
been cited as facilitating accurate pedicle screw placement (although relatively difficult at certain levels and
challenging registration with complex deformities) with high degrees of safety .
[33]

The ROSA Spine by Medtech (stage 2) gained FDA clearance in 2015; similar to the Mazor X system, it
enables pre- and intraoperative CT-based implant trajectory planning and screw insertion over guidewires.
Its most recent version - the ROSA ONE - allows for complete integration with the ROSA ecosystem for
robotic arm accessory attachment. Applications of the ROSA Spine system are not limited but have been
most commonly cited for arthrodesis (e.g., TLIF) with high accuracy [34,35] .

Introduced by Globus Medical in 2017, the ExcelsiusGPS (stage 2) improves pre- and intraoperative
planning similar to the Mazor X and ROSA frameworks, bringing together a rigid robotic arm, surveillance
markers and sensors, and visualization platforms. Relative to fluoroscopy-guided insertion, a GLOBUS-led
study demonstrated accuracy and safety improvements (0% Grade 0 breaches) with significant reductions in
time for placement and exposure to radiation and without the need for Kirschner guidewire placement .
[36]
The system enables the execution of common fusion procedures with better overall alignment and
minimized postoperative complications.

The Renaissance system (stage 1) by Mazor Robotics (acquired by Medtronic) was approved in 2011 and
enables minimally invasive correction of back pain, degenerative pathologies (slipped disk, scoliosis, nerve
impingement), and a range of fusion procedures. The Renaissance consists of a CT/MRI-guided
preoperative image station with trajectory mapping/auto-alignment software, multiple framework arms,
and a robot with 6 DOF; while screw misalignment and skiving are cited concerns with this model, the
Renaissance demonstrates notably low breach rates with some studies citing a 1.1% rate comparable to the
Mazor X - reduced time to procedure completion, and minimal learning curve for users [37,38] .

The SpineAssist (stage 1), another innovation by Mazor Robotics (acquired by Medtronic), is the formal
predecessor to the Renaissance system and gained FDA approval in 2004. Similar to the Renaissance, the
SpineAssist system lacks integrated navigation but provides preoperative imaging (CT) compatible with
intraoperative fluoroscopy. As an earlier iteration, the SpineAssist is unable to flatten bone at screw entry
[39]
points - compounding concerns of skiving - and stalls in processing speed comparisons . However, the
system has achieved consistently clinically acceptable screw placement; Devito et al. reported 98.3% of
placed screws as falling within a defined “safe zone”, with breaches exceeding 2 mm in only 1.7% of
placements across 3,271 total pedicle screws . Notably, they cited no permanent peripheral nerve damage
[40]
in their cohort and particular merits for percutaneous approaches lacking anatomical landmarks.
Nonetheless, the SpineAssist has since been significantly improved in its successors.